Alexza initiates second Phase III study of agitation drug

The trial is an in-clinic, multi-center, randomized, double-blind, placebo-controlled study and will test AZ-004 at two dose levels, five and 10mg. Patients may receive up to three doses of study drug in a 24-hour period, depending on their clinical status. Patients eligible for the study include those who are admitted through an emergency department and those who are already in-patients in a hospital setting, as long as they have acute agitation at the time of patient randomization.

This study is said to be the first AZ-004 study enrolling bipolar disorder patients. Alexza projects that this second Phase III clinical trial will take approximately 12 months to complete patient enrollment.

The primary endpoint for the study is the change from baseline in the positive and negative symptom scale excited component score, measured at two hours after the first dose.

Various assessments of a patient’s agitation state will be conducted at serial time points using standard agitation scales over the first four-hour post-dose time period, with follow-up assessments at the end of the 24-hour study period. Side effects will be recorded throughout the 24-hour period.

Alexza believes that the novel, non-invasive nature and rapid pharmacokinetic properties resulting from inhaled loxapine administration via the Staccato system have the potential to make AZ-004 a viable product to treat acute agitation.

AZ-004 is being developed through Symphony Allegro, a product development partnership formed between Alexza and Symphony Capital. The second AZ-004 Phase III clinical trial is designed to enroll approximately 300 patients diagnosed with bipolar I disorder and acute agitation at 18 US clinical centers.